Innovative Pharma Solutions & Software.
Maximize your success with Masuu Global's
pharma regulatory consulting and software solutions.
We offer expert consulting services & cutting-edge software solutions to streamline all your pharma regulatory & quality processes.
We Cater To
Leading authorities & agencies to deliver solutions that streamline your
business success.
We Are Unique
Why choose us?
We are a team of industry-leading experts with decades of experience in the regulatory and quality domains. Our team's expertise allows us to provide clients with top-notch solutions and services.
We are known for innovative solutions and advanced technological aspects that help our clients achieve their goals. Our team combines expert knowledge with cutting-edge technology to provide clients with the best solutions.
Customer Satisfaction Score (CSAT) - We put customer satisfaction at the forefront of our business. Our team strives to deliver the best possible experience for our clients by providing timely and efficient solutions, ensuring compliance, and maintaining a high level of communication throughout the process.
Truly Unique
Unleashing Innovation
We understand that every client is unique. So, we tailor our approach to meet their specific needs and requirements.
We provide cost-effective solutions and help clients save money while achieving their business goals.
We build long-term partnerships providing ongoing support and guidance as your businesses grow and evolve.
Functional Expertise
Transform organization with expert consultation and proven strategies for success.
Our consultation focus is dedicated towards some of the most critical issues and opportunities that clients face: requirements, strategy, timeline, initiation, execution, transformation, and completion. We provide in-depth domain functional expertise, create values across boundaries and prompt success ratio to the organization. Our prowess is proven strategy delivering absolute solutions to the industry at scale.
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Strategic Insights
Crafting tailored strategies for your success, with global expertise and unmatched precision.
Our strategies planned through core insights into your requirements. With global expertise, accuracy and certainty, we plan and prep things that matter to your success. We believe in creating immeasurable value and fostering long-lasting business partnerships. Your success is our priority, and we strive to make our collaboration more prominent every step of the way.
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Continuous Improvement
Driving excellence for optimal business performance and success.
We strive for continuous improvement in optimizing our business deliverables. Through a strategic execution process, we aim to elevate our standards and provide exceptional value to our clients. Our core focus is enhancing effectiveness, efficiency, and profitability to drive success in every aspect of our services.
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Innovative Deliverables
Innovative solutions, quality delivery, and compliance expertise for success and market leadership.
We help you achieve innovative solutions with the highest quality and shortest timelines. Masuu Global is known for its robust global network of experts in regulatory and quality, we aspire to accomplish customer satisfaction through deliverables with maximum compliance. Our precision matrix helps us deliver the best experience for our clients to make them stand out in the market.
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Our Services
We deliver precise services that are valuable, experiential and
prominent.
Regulatory Affairs
Navigate complex regulations and streamline approvals.
Regulatory Operations
Ensure smooth submissions and compliance.
Regulatory Labeling
Create accurate and compliant product labels.
Quality Compliance & Audit
Maintain high-quality standards and pass audits.
Regulatory Agent
Expert representation for FDA compliance.
Clinical Operations
Efficiently manage clinical trials and research.
Medical Writing
Produce clear and concise regulatory documents.
Pharmacovigilance
Monitor and ensure the safety of pharmaceutical products.
Biostatistics & Trial Monitoring
Gain valuable insights from clinical data.
Over 50,000+ projects
Expert solutions streamlined for business success.
We take pride in our team of experts who are industry leaders and agency veterans with decades of experience. Our organization was established and managed by leading industry professionals, including Global Quality and Regulatory Heads, as well as experts from the Ex-USFDA agency. Our team of 280+ professionals has a combined expertise of 4 decades, and is committed to providing exceptional service and results to our clients.
Our Regulatory & Quality Software
Our regulatory & quality software offer efficient and reliable solutions for managing regulatory compliance, quality control, and document management. Our software is designed to streamline processes, reduce errors, and increase productivity, ensuring that our clients meet regulatory requirements and maintain high-quality standards. With advanced features such as automated workflows, reporting, and audit Trials, our software solutions help our clients achieve compliance while improving efficiency and reducing costs.
NextGen eCTD
Streamline electronic submissions with advanced eCTD solutions.
NextGen SPL
Simplify structured product labeling for enhanced regulatory compliance.
NextGen PDF Plugin
Optimize PDF capabilities for efficient document management.
NextGen eLN
Digitize laboratory workflows with a next-generation electronic lab notebook.
NextGen eDQR
Improve data quality and reporting with advanced electronic data capture solutions.
OUR SUCCESS RECORDS
Discover how we have helped 350+ clients
achieve success through our expertise and innovative solutions.
Regulatory Operations
40000+
Original Application, Amendments, Annual Report, Supplements/Variations etc.
Regulatory Labeling
8500+
PI/SmPC, SPC, Labels/Mock-ups for ANDA, NDA, 505(b)(2), MAA Submission etc.
Quality Compliance & Audits
350+
Successful cGMP, GDP & Quality Compliance Audits (6 Systems Audit) etc.
US Agent Services
200+
US Regulatory Agent services for FDA Correspondence, ER, Self-Identification etc.
Medical Writing
500+
Clinical/Non-clinical Overview, Clinical Study Reports & Safety Reports etc.
PV/Drug Safety
150+
Pharmacovigilance Database & ICSR Management etc.
Language Translation
100+
Technical Documents i.e., Product Dossiers, Master Files & Literatures etc.
What Our
Client's Say
About Us.
Feedback
Masuu Global's regulatory affairs team provided exceptional support in navigating the complex regulatory landscape. Their expertise and guidance helped us achieve regulatory approvals swiftly and smoothly.
HOD - Global Regulatory Affairs Pharma Formulation - India
We were impressed by the depth of knowledge and attention to detail exhibited by Masuu Global in handling our regulatory affairs. Their strategic approach and commitment to excellence have been invaluable to our success.
Director Pharma R&D - USA
Masuu Global is a team of experts with ample knowledge in the process of the pharmaceutical industry, they are the perfect partners for our organisation. We have been doing business with Masuu Global since its inception 2018. Every time we have seen that they come up with new initiatives to ease our submissions process.
Chief Scientific Officer BioPharma - USA
Masuu expertise in delivering the right solutions is prominent to us. The team of Masuu are experts in various US Agent services, GMP Audit, eCTD submissions to different health authorities & their softwares which helped us in achieving our company goals.
Head Quality Pharma API - India
Working with Masuu's Regulatory Labeling team transformed our drug development process. Their expertise in clinical labeling and modular approach streamlined operations. Comprehensive tools like Investigator Brochures and Target Labeling ensured regulatory compliance and successful market entry. Thanks to Masuu, we confidently brought our product to market.
VP Clinical Affairs Pharma Formulation - India
Masuu's regional labeling service expanded our product reach across regions. Their expertise in harmonizing core-to-local labels saved time and resources. With their assistance, we effectively communicated product information to Health Professionals and consumers. Highly recommended for excellent regulatory labeling support.
Director Labeling Affairs
Pharma R&D - USA
Masuu Global are one of the finest consultants I've worked with. Their Quality, Expertise, Commitment & Deliverables is what make them stand out. The management & team are highly knowledgeable, perfectly skilled to complete the challenging tasks for us. I enjoy working with them, will be working with them, will recommend to anyone for regulatory & quality consulting.
Head Regulatory Affairs Drug Store - Jordan
Masuu Global's US regulatory agent services have been invaluable in guiding us through the complex regulatory landscape. Their expertise and support have ensured our compliance and successful submissions. Highly recommended!
Sr. VP - Quality & Regulatory Pharma API - India
Masuu Global's quality compliance and audit services have been instrumental in ensuring our organization meets the highest industry standards. Their meticulous attention to detail and comprehensive approach have helped us identify and rectify potential compliance issues, giving us peace of mind and confidence in our operations.
Director - Quality & Operations CMO - India
Choosing Masuu Global for our quality compliance and audit needs was a game-changer for our company. Their expertise and thorough understanding of quality and regulatory requirements have helped us navigate complex compliance challenges effortlessly. Their team's professionalism and commitment to excellence are truly commendable.
HOD - Quality Assurance
PAPI and Formulation - India
The clinical operation services provided by Masuu Global were exceptional. Their team of experts guided us seamlessly through the complex regulatory processes, ensuring compliance at every step. Their attention to detail and commitment to timelines were instrumental in the success of our business.
Vice President - Clinical
Pharma FDF - India
We engaged Masuu for non-clinical writing services, and their expertise in pre-clinical drug development and safety studies was remarkable. Their toxicologists and scientific writers delivered high-quality documents, including study protocols and reports, contributing to the success of our drug development strategy.
Sr. GM - Regulatory Affairs Pharma Formulation - USA
Masuu Global's forecast and database audits helped us project future results and maintain data accuracy, while leveraging advanced technology for efficient processes. Truly valuable insights!
AGM - Clinical Affairs
Pharma CRO - India
Highly satisfied with Masuu Global's pharmacovigilance services. Invaluable global regulatory expertise for compliance. Streamlined data handling with their safety database management. Trusted partner for pharmacovigilance support.
Director - Research Operations
Pharma R&D - USA
We are highly impressed with the seamless integration and advanced functionality of NextGen eCTD software. It has greatly improved our document management and compliance with regulatory requirements.
VP - Regulatory Affairs
Pharma API - USA
NextGen eCTD software has been a game-changer for us. Its comprehensive tracking and reporting capabilities have made it easier to monitor our submission progress and stay on top of regulatory deadlines.
Director Regulatory Affairs
Pharma Formulation - India
We've been using Nextgen SPL Software for almost an year and it has consistently delivered exceptional results. It has streamlined our labeling workflow and ensured compliance with regulatory requirements.
Sr. Manager - Regulatory Affairs
CMO - India
Nextgen SPL Software has been a crucial tool for our organization. It has made the SPL submission process seamless and error-free, saving us valuable time and resources.
Sr. VP - Regulatory Affairs
Pharma R&D - USA
Contact us today to learn how we can help your business achieve success.Contact Us